CEROXIM Tablet, Suspension Ref.[50620] Active ingredients: Cefuroxime

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2015  Publisher: RANBAXY PHARMACEUTICALS (PTY) LTD, 14 Lautre Road, Stormill, Ext.1, Roodepoort, 1724, South Africa

Product name and form

Ceroxim 250 Tablets.
Ceroxim 500 Tablets.
Ceroxim Suspension.
Ceroxim Forte Suspension.

Pharmaceutical Form

Tablets, Suspension.

Ceroxim 250 Tablets: White coloured, uncoated caplets, engraved with ‘RX751’ on one side and plain on the other.

Ceroxim 500 Tablets: White coloured, uncoated caplets, engraved with ‘RX752’ on one side and plain on the other.

Ceroxim Suspension and Ceroxim Forte Suspension: White to cream-colored granular powder forming white to cream coloured suspension on constitution with water. The resulting suspension has a sweet taste and fruity flavor.

Qualitative and quantitative composition

Ceroxim 250 Tablets

Each tablet contains: Cefuroxime axetil equivalent to cefuroxime 250 mg.

Contains sugar: Sucrose 40 mg.

Ceroxim 500 Tablets

Each tablet contains: Cefuroxime axetil equivalent to cefuroxime 500 mg.

Contains sugar: Sucrose 80 mg.

Ceroxim Suspension

Each 5 ml of constituted suspension contains: Cefuroxime axetil equivalent to cefuroxime 125 mg.

Contains sugar: Sucrose 2,8 g.

Preservative: Sodium benzoate 0,2 % m/v.

Ceroxim Forte Suspension

Each 5 ml of constituted suspension contains: Cefuroxime axetil equivalent to cefuroxime 250 mg.

Contains sugar: Sucrose 2,5 g.

Preservative: Sodium benzoate 0,2 % m/v.

Active Ingredient Description
Cefuroxime

Cefuroxime inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.

List of Excipients

Ceroxim Tablets also contain the following excipients: calcium carbonate, colloidal anhydrous silica (Aerosil-200), croscarmellose sodium, microcrystalline cellulose, monosodium citrate, povidone (K30), purified water, sodium lauryl sulphate, stearic acid and sucrose.

Ceroxim / Ceroxim Forte Suspension also contain the following excipients: aspartame, flavour peppermint, flavour tutti frutti, mannitol, mono sodium citrate, silica colloidal hydrated, sodium chloride and xanthan gum.

Pack sizes and marketing

Ceroxim 250 / 500 Tablets: Cartons containing PVC/Aclar Blister strips of 10 or 5x10 tablets.

Ceroxim and Ceroxim Forte Suspensions are packed in 50 ml and 100 ml HDPE bottle packs, that comprise of natural translucent HDPE bottles with Child resistant closure caps. Each packet also contains a measuring cup with graduated markings. Bottles are labelled and packed in cartons.

Marketing authorization holder

RANBAXY PHARMACEUTICALS (PTY) LTD, 14 Lautre Road, Stormill, Ext.1, Roodepoort, 1724, South Africa

Marketing authorization dates and numbers

Ceroxim 250 Tablets: 34/20.1.1/0349
Ceroxim 500 Tablets: 34/20.1.1/0350
Ceroxim Suspension: 45/20.1.1/0965
Ceroxim Forte Suspension: 45/20.1.1/0966

Drugs

Drug Countries
CEROXIM Ecuador, Nigeria, Poland, South Africa

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